The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.

Ferric chloride (packaging)

SCOGS-Report Number: 35*

Type Of Conclusion: 1

ID Code: 7705-08-0

Year: 1980

21 CFR Section: 184.1297 (1988)

SCOGS Opinion:

The body content of iron in the normal individual is regulated primarily by absorptive processes. Relatively small amounts of iron are absorbed when body stores of iron are high, and relatively large amounts when body stores are low. This regulation of iron absorption is faulty in individuals with the metabolic disorder, hemochromatosis.

Although hemochromatosis is generally considered a rare, genetically transmitted disorder, several investigators believe that a latent form of hemochromatosis may be much more common. In Sweden, where food fortification with iron is at a higher level than in the United States, and where medicinal iroin supplements are widely consumed, investigators reported several cases of hemochromatosis and iron overload in a sparsely populated district. The significance of these findings suggest that it is possible that a significant number of apparently normal and unidentified individuals might be at risk of developing liver damage from intakes of iron which are innocuous and, in fact, probably beneficial for the population at large.

It should be noted that in the United States (and probably inother industrialized countries), individuals ingesting large amounts of iron may achieve these intakes through regular consumption or iron supplements. For these individuals, food fortification contributes a relatively small fraction of total intake. The question of total intake of iron by the U.S. population and its relation to chronic iron toxicity merit further study. Monitoring of the population with respect to iron nutritional status is essential. The estimated per capita intake of 5 mg per day obtained from food fortification comprises more than one-third the total iron intake for much of the population.

Iron deficiency is a leading nutritional problem in the United States. Intakes of iron are below recommended levels for a large fraction of the population. Hence, it is evident that an increase in iron fortification of selected foods could be an important public health measure.

The form of iron utilized to fortify foods should be of adequate bioavailability. Iron forms evaluated in this report which appear to be adequately bioavailable are elemental iron (reduced, electrolytic, carbonyl), ferrous ascorbate, ferrous citrate, ferrous fumarate, ferrous gluconate, ferrous lactate, ferrous sulfate, ferric ammonium citrate, ferric chloride, and ferric citrate. In contrast, the bioavailability of ferrous carbonate, ferrous oxide, ferric oxide, ferric phosphate, ferric pyrophosphate, or ferric sodium pyrophosphate is relatively low compared with ferrous sulfate. Insufficient data are available to judge the relative bioavailability of the other iron preparations considered in this report.

Experimental data are sparse for most of the forms of iron considered in this report. Animal studies have been largely confined to determination of the acute toxicity and bioavailability of specific iron forms. Such studies have limited relevance in evaluating the possible hazards of the addition of iron to foods. Few reports are available on the effects of long-term feeding experiments. An extensive literature exists on the use of certain forms given as hematinics, but the reports are largely anecdotal and their interpretation is of questionable value. Certain compounds have been employed extensively for many years both as additions to food and in the treatment of iron deficiency with no reported adverse effects. In view of the need for, and wide use of, iron compounds, it would appear prudent to place this historical and anecdotal experience on a scientifically rigorous basis in the reasonably near future. The Select Committee emphasizes the need for well-controlled chronic feeding studies with most of the individual compounds, before confident appraisal can be made of their relative merts or hazards.

Several iron compounds are used in the preparation of paper and paperboard materials contacting foods or as ingredients used to hasten the drying of films used in coating the inner surface of food cans. Neither the amounts used for these purposes nor the extent to which they might migrate to foods are known to the Select Committee. However, the extent of their migration to food is believed to be very slight.

The Select Committee concludes that:

There is no evidence in the available information on elemental iron, ferrous sulfate, ferric chloride, ferric oxide, ferric sulfate, iron caprylate, iron linoleate, iron tallate, or the oxides of iron that demonstrates, or suggests reasonably grounds to suspect, a hazard to the public when they are used as ingredients of paper and paperboard materials or in films coating the inner surface of cans in the manner now practiced or that might reasonably be expected in the future.

*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.